I was struck by one particular comment that Professor Guido Rasi, the Executive Director of the European Medicines Agency (EMA) made at our BIA Regulatory Affairs Advisory Committee dinner discussion last week. He said that companies that engage with the EMA early for scientific advice have triple the success in gaining regulatory approval compared to those that don’t. He added that 76% of the companies who sought this advice were large pharma- despite the fact that the process had initially been set up to aid and help smaller companies as they develop drugs.
In its 2011 report the EMA SME office said that the uptake of scientific advice and regulatory assistance by SMEs has remained at a high level, but that many companies were still seeking advice at a late stage or were not taking advice into account in their development. The EMA stressed the importance of opening up an early dialogue with the Agency on all aspects of development, including quality. The EMA encourages companies unfamiliar with the EU regulatory approval process to seek regulatory assistance and approach the SME office to discuss their planned regulatory strategy.
As the still relatively new boy I wonder why companies are not taking up the EMA’s assistance and whether there are things that we as a trade association can do to enable member companies, especially the smaller ones, take up this opportunity, which obviously has consequential benefit.
What are the barriers for small companies to seeking early scientific advice?
- Is it that companies without developed regulatory affairs departments are unaware of the opportunity?
- Is it that using the route is looked upon negatively by investors? Possible but I doubt it.
- Or is it that amongst all the other things that biotech companies have to juggle this issue seems too far off to worry about when the key thing is to get the next piece of research done to get to a milestone.
If so, are we as a sector missing a trick – through using this as a quicker way to improve valuation – or are we scared to ask the question in case the answer isn’t the one we want?
I’d welcome your views – my perception is that regulators are more ready than we might believe to help companies think through their strategies and an early meeting may save time, cost and heartache later down the line.
P.S. I am not sure the early discussion advice argument is jut related to the regulatory field. I’ve also heard similar arguments made about thinking through and engaging on manufacturing (particularly scale up manufacture) and health technology assessment strategies at an early stage in the drug development lifecycle.